Effects of US-guided SAPB During Breast Surgery

February 11, 2022 updated by: Çağdaş Baytar, Zonguldak Bulent Ecevit University

The Effects of Ultrasound-guided Serratus Anterior Plane Block on Intraoperative Opioid Consumption and Hemodynamic Stability During Breast Surgery: A Randomized Controlled Study

The serratus anterior plan (SAP) block is a technique that has recently gained popularity in the context of breast surgery. SAP block resulted in better hemodynamic stability, early ambulation and shorter hospital stay, as well as hospital costs for postoperative breast patients.

We aimed to investigate the effects of the serratus anterior plane block in women undergoing breast surgery, in the intraoperative period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kozlu
      • Zonguldak, Kozlu, Turkey, 67600
        • Zonguldak Bülent Ecevit University Medicine Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Between the ages of 18-75,
  • ASA I-II-III risk group
  • Patients who underwent breast surgery under general anesthesia, who underwent serratus anterior plan block for analgesia, or who were provided analgesia with conventional methods
  • Patients whose informed consent was read and whose consent was obtained

Exclusion Criteria:

  • who do not want to participate in the study,
  • ASA IV-V patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control group
Active Comparator: Serratus anterior plane block
Procedure: Serratus anterior plane block
local anesthetic application between serratus anterior muscle and 5th rib

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hemodynamic stability
Time Frame: during surgery
effect of serratus anterior plane block on hemodynamic stability during breast surgery
during surgery
opioid consumption
Time Frame: during surgery
effect of serratus anterior plane block on opioid consumption during breast surgery
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emergence time
Time Frame: end of the surgery
the time period between surgical incision closure and extubation.
end of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zonguldak Bulent Ecevit University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

August 31, 2021

Study Completion (Actual)

September 30, 2021

Study Registration Dates

First Submitted

March 29, 2021

First Submitted That Met QC Criteria

March 29, 2021

First Posted (Actual)

April 1, 2021

Study Record Updates

Last Update Posted (Actual)

February 16, 2022

Last Update Submitted That Met QC Criteria

February 11, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021/03-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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